1. Field of the Invention
The invention relates to hormone therapy as a treatment for patients with symptoms consistent with multiple sclerosis.
2. Background
It is known that the levels of a variety of hormones drop substantially with age. These include human growth hormone, sex hormones, pineal, adrenal, thyroid, and thymus hormones. Hormonal replenishment methods employed as anti-aging treatments have been developed. An example of such method is described in U.S. Pat. No. 8,855,920. The utility of this method in connection with certain degenerative diseases, often associated with hormonal deficiencies due to aging, is also known in the art.
In contrast, Multiple Sclerosis (MS) is not a disease associated with degenerative conditions associated with old age. Rather, MS strikes mainly young adults and is the most common neurologic cause of disability in that age group. Overall, MS affects approximately 300,000 Americans.
MS is thought to be an autoimmune illness, wherein the immune system mistakenly recognizes normal brain and spinal tissue as "foreign" and attacks them, resulting in inflammation and damage. Myelin, the insulative material surrounding axons in nerve cells, are particularly affected by MS. In patients, the inflammation disrupts myelin, sometimes destroying the axons thus impeding the connections between nerve cells. The region of demyelination and inflammation within the brain or spinal cord is called a "plaque" and ranges anywhere from millimeters to more than a centimeter in diameter.
Actual MS symptoms appear to reflect the number and severity of plaques as well as their location at important sites within the nervous system. Mild sensory symptoms, e.g., tingling, burning, itching, may result. Typically, however, no diagnosis of MS is made until severe symptoms develop, such as weakness, paralysis or numbness of limbs, loss of vision, imbalance, chronic pain or chronic fatigue. The long term consequences of MS can be very debilitating. In some studies, 50% of patients were disabled within ten years and fewer than two thirds were able to walk after thirty years.
In common diagnosis, MS is found by excluding all other potential conditions from consideration. Formerly diagnostic chemical tests of cerebro-spinal fluid determined the presence of MS. This, however, has given way in recent years to magnetic resonance imaging (MRI) scans of the brain as the preferred diagnostic method. Brain MRI scans are abnormal in the vast majority of MS victims. Areas of abnormal brightness, suggesting increased water content, appear on "T2 weighted" scans; dark areas on "T1 weighted" scans suggest focal areas of tissue destruction; and abnormal brightness after a dye is injected for enhancement into the patient's bloodstream suggest that inflammation has damaged the blood-brain barrier. Again, as these symptoms are present also in other neurologic conditions, the diagnosis of MS is not made from these symptoms alone. This diagnosis results by testing done over time.
Various drugs, including natural immune substances such as beta-interferon, have proved effective in treating the physical symptoms of MS and reducing their frequency. Recently studies with animals employing induced experimental autoimmune encephalomyelitis (EAE), an animal model of MS, has shown that growth factor hormones, including Insulin-like Growth Factor hormones (IGF) may promote myelin regeneration, reducing and sometimes eliminating inflammatory lesions and reducing other clinical deficits in EAE subjects. In one study adult female mice having induced EAE were injected subcutaneously with 0.6 mg of IGF over a ten day period. Another group of EAE-induced mice were given placebos. Those treated with IGF-I exhibited reduced deficits and reduced numbers and sizes of inflammatory, demyelinating and demyelinated lesions.